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Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01) (COVITOZ-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435717
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jose A Perez Molina, Hospital Universitario Ramon y Cajal

Brief Summary:
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) Phase 2

Detailed Description:

National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved.

The study is designed to evaluate the effect of adding Tocilizumab to standard or standard of care for patients infected with COVID-19 and diagnosed with mild-moderate pneumonia.

78 patients are expected to be included in the study in a single center in Spain. The study includes a selection and randomization period, and a 28-day follow-up period (or until death, or premature withdrawal, whichever is earlier). Once the patients complete the study, they will continue with their usual follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Patients eligible to be included in the study will be randomized in a 1: 1: 1 ratio to receive:

  • TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
  • TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment
  • Usual / standard care treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : August 4, 2020
Estimated Study Completion Date : August 4, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: TCZ 8 mg / kg one dose
TCZ 8 mg / kg (with a maximum of 800 mg) in single dose + usual treatment
Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1
Tocilizumab 20 MG/ML Intravenous (one dose)

Experimental: TCZ 8 mg / kg in two
TCZ 8 mg / kg in two doses at 0 and 12 hours (with a maximum of 800 mg per dose) + usual treatment
Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)
Tocilizumab 20 MG/ML Intravenous ( two doses)
Other Name: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1

No Intervention: standard care treatment
Usual / standard care treatment



Primary Outcome Measures :
  1. Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3. [ Time Frame: Day1 and Day3. ]
    Average increase in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.


Secondary Outcome Measures :
  1. Progression of pneumonia [ Time Frame: Day3, Day7 and Day28 ]
    Percentage of patients per group with progression of pneumonia in Day3, Day 7 and Day28

  2. PaO2/FiO2 [ Time Frame: Day3, Day7 and Day28 ]
    Proportion of patients with PaO2 / FiO2 <300 (or SatO2 / FiO2 ≤315) at some point in the evolution.

  3. cause mortality to 28 days after started treatment [ Time Frame: Day3, Day7 and Day28 ]
    cause mortality to 28 days after started treatment

  4. Length of hospital stay [ Time Frame: Day3, Day7 and Day28 ]
    Length of hospital stay

  5. patients requiring Intensive Care Unit admission [ Time Frame: Day3, Day7 and Day28 ]
    Percentage of patients requiring Intensive Care Unit admission

  6. evolution of inflammatory parameters IL12 [ Time Frame: Day0, Day3 and Day7 ]
    IL-12 levels at Day 7

  7. evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma [ Time Frame: Day0, Day3 and Day7 ]
    IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels on days Day 0, Day1, Day 3 and Day 7

  8. evolution of inflammatory parameters Procalcitonin (PCT), [ Time Frame: Day0, Day3 and Day7 ]

    Procalcitonin (PCT), levels on days Day0, Day1, Day3 and Day 7

    • 7

  9. evolution of inflammatory parameters C-reactive protein (PCR), [ Time Frame: Day0, Day3 and Day7 ]

    C-reactive protein (PCR),levels on days Day0, Day1, Day3 and Day 7

    • 7

  10. evolution of inflammatory parameters D-dimer [ Time Frame: Day0, Day3 and Day7 ]

    D-dimer levels on days Day0, Day1, Day3 and Day 7

    • 7

  11. evolution of inflammatory parameters and ferritin [ Time Frame: Day0, Day3 and Day7 ]

    ferritin levels on days Day0, Day1, Day3 and Day 7

    • 7

  12. pharmacokinetics of tocilizumab Cmin [ Time Frame: Day0, Day1 Day3 and Day7 ]
    Cmin,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

  13. pharmacokinetics of tocilizumab Cmax [ Time Frame: days Day0, Day1 Day3 and Day7 ]
    Cmax,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

  14. pharmacokinetics of tocilizumab Cmedia [ Time Frame: days Day0, Day1 Day3 and Day7 ]
    Cmedia,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

  15. pharmacokinetics of tocilizumab Tmax [ Time Frame: days Day0, Day1 Day3 and Day7 ]
    Tmax,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

  16. pharmacokinetics of tocilizumab AUC [ Time Frame: days Day0, Day1 Day3 and Day7 ]
    AUC,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

  17. Adverse event [ Time Frame: days Day0, Day3, Day7 and Day28 ]
    Serious and non-serious adverse events.

  18. Adverse event to cause the treatment interruption. [ Time Frame: days Day0, Day3, Day7 and Day28 ]
    Adverse events to cause the treatment interruption.

  19. Adverse event Abnormalities in laboratory [ Time Frame: days Day0, Day3, Day7 and Day28 ]
    Abnormalities in laboratory findings unrelated to COVID-19 disease.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
  2. The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:

    to. Basal oxygen saturation> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315

  3. The patient is hospitalized or meets hospital admission criteria.
  4. The patient is not expected to enter the ICU or die in the next 24 hours.

Exclusion Criteria:

  1. Participants in another simultaneous clinical trial.
  2. Use of other immunomodulators.
  3. Coinfection with the hepatitis B virus (detectable AgSup-HBV).
  4. Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
  5. Presence of laboratory abnormalities of grade ≥ 4.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435717


Contacts
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Contact: Jose A Perez-Molina, PhD +34913368108 jperezm@salud.madrid.org

Locations
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Spain
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Jose A Perez-Molina, PhD    +34913368108    jperezm@salud.madrid.org   
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
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Responsible Party: Jose A Perez Molina, Sponsor, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT04435717    
Other Study ID Numbers: COVITOZ-01
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pharmaceutical Solutions